INSYS Therapeutics announced that its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing.
INSYS’ naloxone nasal spray is a single unit dose spray device that delivers 8mg naloxone dose.
“The FDA’s acceptance of the NDA for INSYS’ proprietary formulation of a naloxone nasal spray is an important milestone in battling the U.S. opioid epidemic,” said Dr. Venkat Goskonda, chief scientific officer at INSYS Therapeutics.
“We believe our formulation has the potential to be a critical tool in combatting opioid overdose cases. The rapid absorption and significant exposure of the formulation may be useful in opioid overdose, particularly with the rise of synthetic opioid use.”
The Centers of Disease Control and Prevention reported 70,237 drug overdose deaths in the United States in 2017 of which 47,600 involved opioids.
INSYS Therapeutics is a specialty pharmaceutical company using proprietary technology and capabilities to develop and commercialize innovative pharmaceutical products intended to address unmet medical needs and the clinical shortcomings of existing commercial products.
Source: Company Press Release